The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Rheumajet Rf.
Device ID | K910539 |
510k Number | K910539 |
Device Name: | RHEUMAJET RF |
Classification | System, Test, Rheumatoid Factor |
Applicant | BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186 |
Contact | Ignacio Odriozola |
Correspondent | Ignacio Odriozola BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186 |
Product Code | DHR |
CFR Regulation Number | 866.5775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-28 |
Decision Date | 1991-04-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00613647001295 | K910539 | 000 |
00613647001264 | K910539 | 000 |
00613647001257 | K910539 | 000 |